FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
K Number: K013988
·
Decision Apr 4, 2002
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
30
Review Days
121
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Basic Information
- Device Name
- MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
- K Number
- K013988
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5130
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Millipore Corp.
- Date Received
- December 4, 2001
- Decision Date
- April 4, 2002
- Product Code
- BSN
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BSN | Filter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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Other Clearances by Millipore Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | Jan 17, 2003 | Substantially Equivalent |
| K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) | Jun 10, 1997 | Substantially Equivalent |
| K941326 | ULTRAFREE-CL | May 27, 1994 | Substantially Equivalent |
| K934069 | MILLEX, DUALEX (PLUS, ULTRA) | Apr 21, 1994 | Substantially Equivalent |
| K924347 | WATERS(TM) 996 PDA | Dec 11, 1992 | Substantially Equivalent |
| K922388 | WATERS(TM) LC MODULE I FOR CLINICAL USE | Sep 11, 1992 | Substantially Equivalent |
| K920136 | WATERS 717 AUTOSAMPLER | Feb 19, 1992 | Substantially Equivalent |
| K914841 | CHROMATOGRAPHY CLINICAL USE 75JQR | Dec 10, 1991 | Substantially Equivalent |
| K903647 | MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE | Sep 11, 1990 | Substantially Equivalent |
| K872792 | WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM | Jul 31, 1987 | Substantially Equivalent |